Document pp32B6KL2G8oVYarqqJamve87

Summary N-ETFOSERatTeratology SLu&Numbers:3M T-6316.7A,rgus418-011 Comi)ound&Lot: N-ETFOSE (N-Ethyl-PerfluoroocyanesulfonamidoEdm-oLlo)t FM3923 (30035, 30037,30039) 98.2% pure(SMD AnalyticaRlequest52489) AnalyticaDlocumentationfiledalongwith finalreport.Note - same lotas used intwo-yearratcarcinogenicitsytudy(T-6316,Covance 6329-212). StudyTitle:Oml (Gavage)DevelopmentalToxicityStudyofN-ETFOSE in Rats E.eportDate: 17 December 1998 StudyMonitor Summary: (writtebny Marvin T. Case) Pregnantratfemales,25 pergroup,were given dailyoral(intubatioonf)N-ETFOSE atdose levelsof 0, 1,5, 10,and 20 mg/kgldayon days6 through17 of gestationT.he ratfetuseswhich had been exposed inuteroduringorganogensiswere collectedatday 20 of gestation.Approximatelyone-halfofthefetuseswere examined forsofttissue(visceralc)hangesand other halfwere examined forskeletaclhanges. There were no compound relatecdlinicaslignsoftoxicitiynthedosedratdams. A body weighteffect, reducedbody weight gains,occurredinthepregnantfemalesinhighesttwo doselevels- 10 & 20 mg/kg. Thisbody weighteffecctorrelatewdithreducedfood consumptioninthesame two groups.The matemal toxicitayt 10 & 20 mg/kg was reflecteidnthepups as reducedpup weights.Therewas no effecton other litteprarameters(corporaluteai,mplantationsl,ittesrize,number oflivefetus,earlyorlateresorptionsp,up sex ratioa)tany dose level.Increaseddelayedossificatiosnitewsere found in 10 & 20 mg/kg fetusesanotherreflectioonfmatemal toxicitaytthesedose levels. No compound-relatedsofttissueor skeletamlalformationswere found atany doselevel.Thus,the compound was not foundtobe teratogeniicntherat The matemal toxicNOEL was 5 mg/kg. The fetaltoxicNOEL was also5 mg/kg. TeratogenicNOEL inthemt was > 20 mg/kg. NOTE: Dose preparatiosnampleswere collectetdwiceduringthestudyand thesesampleswere sentto 3M EvironunentalAnalyticalaboratoriynBldg 2. Likewise,sampleswere collectefdrom extrafemales assignedas toxicokinetiscatelliatneimals(3/groupexceptcontroland high dose5/group).These animals were killedon gestationday 18 (dayafterlastdose)and thefollowing&wipleswere collecteds:enun and liverfrom pregnantdams,fetusesand placentas(pooledby litterf)iromuterus.These sampleswere frozen and sentto 3M EvironunentalAnalyticalaboratoryinBldg 2. At timeof thissummary, January1999, analysisof thesesamples had notbeen done;thereforet,heseanalyticarlesultwsere not includedinthe finalrepoitnor inthissununary.